Vascular closure

ABSTRACT

An apparatus for closing an aperture comprising a horizontally extending member and elongated strand portions having extremity portions curving inwardly. The extremity portions have shape memory characteristics seeking to cause the extremity portions to curl to retain tissue engaged thereby when delivered from a delivery member. A central portion extends between the horizontally extending member and the elongated strand portions.

CROSS-REFERENCE TO RELATED PATENT APPLICATION

This application is a continuation of U.S. application Ser. No.10/269,899, filed Oct. 11, 2002 now U.S. Pat. No. 6,749,622 which is acontinuation of application Ser. No. 09/659,648, filed Sep. 12, 2000 nowabandoned which claims priority from provisional application No.60/153,736, filed Sep. 13, 1999.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to methods and apparatus for closing apertures inhuman and animal tissue and to methods and apparatus for insertingapparatus into such tissue to perform such closure functions.

2. Description of the Prior Art

During certain types of vascular surgery, catheters are inserted throughan incision in the skin and underlying tissue to access the femoralartery in the patient's leg. The catheter is then inserted through theaccess opening made in the wall of the femoral artery and guided throughthe artery to the desired site to perform surgical procedures such asangioplasty or plaque removal. After the surgical procedure is completedand the catheter is removed from the patient, the access hole must beclosed. This is quite difficult not only because of the high blood flowfrom the artery, but also because there are many layers of tissue thatmust be penetrated to reach the femoral artery.

Several approaches have used to close femoral access holes. Typically,manual compression by hand over the puncture site can be augmented by asandbag or weight until the blood coagulates. With this approach it cantake up to six hours for the vessel hole to close and for the patient tobe able to ambulate. This increases time for the surgical procedure aswell as overall cost of the procedure since the hospital staff mustphysically hold pressure and the patient's discharge is delayed becauseof the inability to ambulate. This is not an efficient use of either thepatient's or staff's time. After some procedures, to close the vesselpuncture site a clamp is attached to the operating table and thepatient's leg; The clamp applies pressure to the vessel opening. Thepatient must be monitored to ensure the blood is coagulating, requiringadditional time of the hospital staff and increasing cost of theprocedure.

To avoid the foregoing disadvantages of manual pressure approaches,suturing devices have been developed. One such suturing device, referredto as “The Closer” and sold by Perclose, advances needles adjacent thevessel wall opening and pulls suture material outwardly through the walladjacent the opening. The surgeon then ties a knot in the suture,closing the opening. One difficulty with this procedure involves thenumber of steps required by the surgeon to deploy the needles, capturethe suture, withdraw the suture, and tie the knot, and cut the suture.Moreover, the surgeon cannot easily visualize the suture because of thedepth of the femoral artery (relative to the skin) and essentially tiesthe suture knot blindly or blindly slips a pre-fabricated knot intoposition. Additionally, the ability to tie the knot varies amongsurgeons; therefore success and accuracy of the hole closure can bedependent on the skill of the surgeon. Yet another disadvantage of thissuturing instrument is that the vessel opening is widened for insertionof the instrument, thus creating a bigger opening to close in the caseof failure to deliver the closure system.

It would therefore be advantageous to provide an instrument whichquickly and accurately closes holes in vessel walls. Such instrumentwould advantageously avoid the aforementioned time and expense of manualpressure, simplify the steps required to close the opening, and avoidwidening of the opening.

SUMMARY OF THE INVENTION

The present invention overcomes the disadvantages and deficiencies ofthe prior art by, in one of its aspects, providing clip apparatus forclosing a lumen aperture, particularly a vascular aperture, resultingfrom insertion of a surgical implement subsequent to completion of aninvasive therapeutic procedure and withdrawal of the implement from theaperture where the apparatus includes an elongated strand comprising acentral portion together with extremity portions extending from thecentral portion. The apparatus further involves tips of the extremityportions remote from the central portion being shaped to retain apertureperipheral tissue encountered thereby with the extremity portions havingmemory characteristics seeking to cause the extremity portions to curltowards and over one another about the central portion when the strandis in an unconstrained disposition, free of externally applied stress.Preferably, the apparatus is deployed in a two stage operation wherebythe clip apparatus is initially deployed partially from a deliveryapparatus with tips of the extremity portion contacting and thepenetrating the interior surface of tissue of the vessel and acts todraw the aperture closed. In a second step the apparatus is fullydispensed from the delivery portion; tips of extremity portion of theapparatus do not penetrate the vessel tissue in the region about theaperture to be closed but act to draw the subcutaneous fascia on top ofthe outside aspect of the aperture. The two stage deployment of theclosure apparatus results in a ratchet-type action by the deploymentapparatus thereby providing extreme tactile sensitivity for thephysician or other health professional handling the apparatus withresulting high sensitivity to the location of the apparatus and greatersafety for the patient than otherwise possible.

In another of its aspects, this invention provides clip apparatus forclosing a aperture, particularly a vascular aperture resulting frominsertion of a surgical implement, into subsequent to completion of aninvasive therapeutic procedure and withdrawal of the implement from theresulting aperture. In this aspect of the invention, the apparatusincludes a plurality of elongated strands with each strand including acentral portion and extremity portions extending from the centralportion. Tips of the extremity portions remote from the central portionare shaped to retain aperture peripheral tissue encountered thereby. Theextremity portions have memory characteristics seeking to cause theextremity portions to curl towards and about the central portion whenthe strand is in an unconstrained disposition, free of externallyapplied stress.

The clip apparatus may further include a band circumferentiallyenveloping the strands proximate the longitudinal midpoints of thestrands for retaining the strand midpoints in close proximity to oneanother as the tip portions curl towards and about the midpoints. Theband is preferably bonded to the strands.

The clip apparatus may further include a longitudinally elongated memberextending from the central portions of grouped strands substantially inthe longitudinal direction with respect thereto for facilitatinggripping and guiding the strand portions of the clip member. Thelongitudinally elongated member is preferably rigid relative to thestrand members.

In yet another of its aspects this invention provides a clip formed froma one piece integral strand, serving to close a lumen aperture such as avascular aperture resulting from the insertion of a surgical instrument,where the clip includes an elongated strand of ribbon-like configurationhaving a central portion and extremity portions extending in oppositedirections from the central portion. The central portion assumes alinear configuration and the extremity portions extending from thecentral portion assume configurations in which first parts of theextremity portions proximate the central portion curve towards oneanother and towards the central portion and second parts of theextremity portions relatively more remote from the central portion curveaway from one another and from the central portion to position arcuatetips of the extremity portion sufficiently skew to the central portionthat tissue around the periphery of the aperture which is punctured bythe extremity portions is retained between the tip portions as the cliprelaxes.

In yet another of its aspects this invention provides apparatus forclosing an aperture such as a vascular aperture resulting from insertionof a surgical instrument into where the apparatus includes a telescopingtubular housing and clip apparatus resident within the housing forclosing the aperture. In this aspect of the invention, the clipapparatus preferably includes a plurality of elongated strands with eachstrand having a central portion and extremity portions extending fromthe central portion. Tips of the extremity portions remote from thecentral portion are shaped to retain aperture peripheral tissueencountered thereby. The extremity portions have memory characteristicsseeking to cause the extremity portions to curl towards and about thecentral portion of a respective strand when the strand is in anunconstrained disposition, free of externally applied stress.

In this aspect of the invention, the clip preferably further includes aband circumferentially enveloping the strands proximate the longitudinalmidpoints thereof for retaining the strand midpoints in close proximityto one another as the tip portions curl towards and about the midpoints.In this aspect of the invention, the clip preferably further includes alongitudinally elongated member extending from the central portions ofthe strands substantially in the longitudinal direction with respectthereto and serving to facilitate gripping and guiding of the strandportions of the clip member. The strands, the band and thelongitudinally elongated member are preferably bonded togetherintegrally and reside in a housing. The housing is operable to dispensethe clip from one end upon relative movement between telescopingsections of the housing.

In another aspect of the invention the housing may be tubular but nottelescoping.

When the housing is telescoping, the housing may include at least two(2) telescoping sections and may operate to dispense the clip in a two(2) stage operation in which first relative movement between thetelescoping sections results in a first portion of the clip beingdispensed from the housing and additional relative movement between thetelescoping section results in the remaining portion of the clip beingdispensed from the housing.

In this aspect of the invention, the clip may further include afilament, positioned within the housing, connecting the clip to thehousing with the filament preferably being connected to a longitudinalmember portion of the clip. The filament is preferably flexible.

In this aspect of the invention, the longitudinal member portion of theclip preferably includes a loop formed therein thereby presenting atransverse passageway through the longitudinal member.

The housing preferably further includes a safety member for precludingsecond telescoping movement of the telescoping sections of the housingafter the first telescoping movement until a safety member has beenreleased.

In yet another of its aspects, this invention embraces a method forclosing a vascular or other aperture resulting from, for example,insertion of the surgical implement thereinto subsequent to thecompletion of invasive therapeutic procedure and withdrawal of theimplement from the aperture. The method includes providing an elongatedstrand comprising a central portion and extremity portions extendingfrom the central portion with tips of the extremity portions remote fromthe central portion being shaped to retain aperture peripheral tissueencountered thereby with the extremity portions having memorycharacteristics seeking to cause the extremity portions to curl towardsand over one another about the central portions when the strand is in anunconstrained disposition, free of externally applied stress.

The method further embraces dispensing the elongated strand from atubular housing partially into the lumen aperture sufficiently far forthe dispensed portion, consisting of the strand from an extremity to acentral portion, to curl about and towards the strand central portionthereby to encounter tissue positioned immediately about the peripheryof the aperture and to draw the aperture peripheral tissue radiallyinwardly relative to a longitudinal axis of the strand. In this aspectof the invention the method further embraces dispensing the remainingportion of the strand from a housing thereby permitting the remainingportion of the strand, from the central portion to a second strandextremity, to curl about and towards the central to of the vessel anddrawing surrounding subcutaneous fascia radially inwardly relative tothe longitudinal axis of the strand thereby substantially augmentingclosure of the vessel, puncture site of the vessel external compression.

In yet another of its aspects this invention in a preferred embodimentprovides clip apparatus for closing an aperture in tissue where theapparatus includes a first portion forming an arc, a second portionextending transversely from the first portion relative to the arc and athird portion extending from the second portion remotely from the firstportion, with the third portion curving progressively relative to thesecond portion initially towards the first portion and then towards thesecond portion with a tip of the third portion being adapted forpiercing and retaining tissue encountered thereby. In this aspect theinvention further preferably includes at least two third portionsextending from the second portion at a common position with the thirdportions curving progressively first towards the first portion and thentowards the second portion and each other.

In this aspect the invention may further embrace clip apparatus having apair of second portions respectively connected to parts of the firstportion separated by the arc and extending transversely to the arc in acommon direction relative thereto with a pair of third portionsextending from respective ones of the second portions, curvingprogressively first towards the first portion and then simultaneouslytowards the second portion and each other.

In this aspect of the invention extremities of the third portionsdesirably contact the second portions, the second portions arepreferably linear and the curved segments of the third portions arepreferably separated by linear segments.

In this aspect of the invention the first portion is preferablyconfigured as a figure eight.

In this aspect of the invention the second portion preferably extendsaway from the first portion perpendicularly to a plane of the arc.

When the first portion is configured as a figure eight the secondportion preferably extends away from the center of the figure eightconfiguration.

In this aspect of the invention the first portion further preferably hasat least two arcs separated by a straight segment. Further, at least oneof the arcs preferably subtends an angle of greater than one hundredeighty degrees.

Still further, the arcs preferably each have straight segments adjoiningthe ends of the arcs and connecting with the second portions. In thisaspect of the invention both of the arcs preferably subtend an angle ofgreater than one hundred eighty degrees. The second portions arepreferably straight and the linear segments of the third portions arepreferably straight.

In another aspect this invention provides apparatus for closing anaperture in tissue where the apparatus includes an elongated unitarystrand having a central portion and extremity portions extending fromthe central portion. Tips of the extremity portions remote from thecentral portion are preferably pointed to engage and retain tissueencountered thereby. The strand is preferably configured so that thetips are at ends of respective curved portions and face towards oneanother when the clip is in an unconstrained state, free of internalstresses. The strand preferably has a memory characteristic causing theclip, when unconstrained, to seek to return to an unstressed state withthe tips seeking to draw together sufficiently to retain tissue engagedby the tips for closing the aperture and retaining the subcutaneoustissue at the exterior surface of the aperture causing externalcompression by the tips.

In this aspect of the invention the strand preferably further includes apair of mid-portions intermediate the tips and the central portion withthe central portion disposed in a first plane and the mid-portiondisposed in a plane transverse to the first plane. The mid-portionpreferably has a linear part connected to the central portion andextending transversely therefrom.

Preferably, the central portion is configured to have at least one loopsubtending an angle of at least about 180 degrees.

In this aspect of the invention the loop is preferably closed by overlapof the strand upon itself, the central portion preferably lies in aplane, the extremity portions are preferably in a plane transverse tothe plane of the central portion and the tips are preferably at ends ofthe curved portions of the strand, with the tips being closer to thecentral portion than to the curved portions of the strand supporting thetips.

In this aspect of the invention an upper portion of the apparatus ispreferably configured as a figure eight. This apparatus aspect of theinvention further has the strand preferably having a mid-portionintermediate the tips and the central portion, extending transversely tothe central portion with the tips facingly opposing one another oneither side of the mid-portion and pointing away from the centralportion in a common direction. The mid-portion is preferablyperpendicular to the central portion; the central portion preferablyincludes a plurality of loops.

In this aspect of the invention the strand is preferably metal and ismost preferably a filament. The strand may include at least twofilaments.

In this apparatus aspect of the invention the central portion mayinclude at least two preferably co-planar loops.

In another aspect, this invention provides apparatus for inserting asurgical clip which is housed therewithin into tissue to close anaperture in the tissue where the apparatus includes a first handleportion housing a tubular member and having a hand grip extendingtransversely therefrom where the tubular member is connected to thehandle portion and extends generally longitudinally from the handleportion. Surgical clip positioning means are preferably provided at adistal end of the tubular member remote from the handle. A clip loadingwire is preferably provided looping around the clip, residing at leastpartially within the tubular member at a distal end thereof, extendingalong the length of the tubular member and exiting from the handleportion at a proximate end of the tubular member. The apparatuspreferably further includes a clip pusher member movable axially withinthe tubular member through a range of motion from a first through anintermediate to a second position for displacing the clip from withinthe tubular member in two stages. The clip is housed within theapparatus and is ready for insertion into the lumen when the pushermember is at the first position. The clip extends partially from thetubular member when the pusher member is at the intermediate position;the clip is separated from the apparatus and presumably within thetissue of interest closing the targeted aperture when the pusher memberis at the second position.

In this aspect of the invention the surgical clip insertion apparatuspreferably further includes a ring connected to the wire with the ringbeing detachably mounted on the handle portion at the proximate end ofthe tubular member. The ring facilitates hand powered movement of theloading wire to draw the clip at least partially into the tubularmember.

Preferably in this aspect of the invention the clip positioning meansserves to position the clip angularly within the tubular member; mostdesirably the clip positioning means are slots formed in the tubularmember with the slots communicating with the distal end of the tube.Most desirably the slots correspond in number to the number of tissuepenetrating points of the surgical clip housed within the apparatus.Further desirably the clip positioning means served to position thesurgical clip longitudinally within the tubular member.

In yet another aspect the invention provides apparatus for inserting asurgical clip into tissue to close an aperture in tissue where theapparatus includes a first handle portion, a tubular member connected tothe handle portion and extending generally transversely therefrom, aclip loading member pivotally connected to the tubular member andmoveable between positions at which the clip is loaded into theapparatus and at which the clip is housed within the apparatus and readyfor insertion into the tissue and a clip trigger member which ismoveably axially within the tubular member through a range of motionfrom a first through an intermediate to a second position for displacingthe clip from the tubular member in two stages. The clip is desirablyhoused within the apparatus and ready for insertion into tissue when thetrigger is at the first position. The clip preferably extends partiallyfrom the tubular member when the trigger is at the second position. Theclip is preferably separated from the apparatus and presumably insertedinto tissue and closing the aperture of interest when the trigger is atthe third position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a surgical tissue closure clipmanifesting the preferred embodiment of the clip aspect of theinvention, with a vertical axis designated “A” shown for referencepurposes.

FIG. 2 is a front view of the clip illustrated in FIG. 1 with verticalaxis A and a horizontal axis shown for reference purposes and withreference lines 64 and 66 designating respective upper and lowerportions of the clip.

FIG. 3 is a side view of the clip illustrated in FIGS. 1 and 2, lookingfrom left to right in FIG. 2.

FIG. 4 is a top view of the clip illustrated in FIGS. 1, 2 and 3.

FIG. 5 is a bottom view of the clip illustrated in FIGS. 1, 2, 3 and 4.

FIG. 6 is a broken vertical section of a preferred embodiment of a clipin accordance with the invention as illustrated in FIGS. 1 through 5 inposition ready for deployment from a clip delivery member manifestingthe preferred embodiment of delivery apparatus in accordance with theinvention.

FIG. 7 is a broken vertical section of a preferred embodiment of a clipin accordance with the invention as illustrated in FIG. 6 in the processof being deployed from within a clip delivery member and inserted into avessel. In FIG. 7 the clip is illustrated at the intermediate positionfrom which the physician or other attending healthcare professional maywithdraw the clip back into the position illustrated in FIG. 6 or maycontinue to eject and deploy the clip into the position illustrated inFIG. 8 whereby tip members of the clip have penetrated the vessel walland served to at least substantially close an aperture therein.

FIG. 8 is a broken vertical section similar to FIG. 7 of a preferredembodiment of the clip shown in FIG. 6 penetrating a wall of the vesselas the clip delivery apparatus is withdrawn. In FIG. 8 the clip isillustrated fully deployed and ratcheting operation is complete.

FIG. 9 depicts a preferred embodiment of the clip in accordance with theinvention shown in FIGS. 1 through 8 in position within a vessel wall inan unconstrained configuration, closing an aperture in the wall.

FIG. 9A is an enlarged view of the clip depicted in FIG. 9 showing theclip within a vessel wall in an unconstrained configuration at leastsubstantially closing an aperture in the vessel wall.

FIG. 10 is an enlarged broken isometric view of the front end of clipdelivery member and clip as illustrated in FIGS. 1, 2, 3, 4 and 5 inaccordance with the invention.

FIG. 11 is a front elevation of a preferred embodiment of a clipdelivery member in accordance with the invention, partially broken awayto reveal interior details.

FIG. 12 is a front elevation of the preferred embodiment of the clipdelivery member illustrated in FIG. 11.

FIG. 13 is an enlarged isometric view of a preferred embodiment of aclip shown in FIGS. 1, 2, 3, 4 and 5 with lines added to the surface tofacilitate identification.

FIG. 14 is identical to FIG. 13 but without the added surface lines.

FIG. 15 is a front quarter view of a second embodiment of a tissueclosure clip in accordance with the invention.

FIG. 16 is a side view of the clip illustrated in FIG. 15.

FIG. 17 is a front view of the clip illustrated in FIGS. 15 and 16.

FIG. 18 is a bottom view of the clip illustrated in FIGS. 15, 16 and 17.

FIG. 19 is a top view of the clip illustrated in FIGS. 15, 16, 17 and18.

FIG. 20 is a top view of a third embodiment of a tissue closure clipmanifesting aspects of the invention.

FIG. 21 is an isometric view of the closure clip illustrated in FIG. 20.

FIG. 22 is an isometric view of the tissue closure clip illustrated inFIGS. 20 and 21 being dispensed from a portion of a telescoping housing.

FIG. 23 is a broken, partially sectioned side view of another embodimentof a clip delivery member in accordance with the invention in placewithin tissue ready to eject a clip into place to close an aperture in avessel.

FIG. 24 is an isometric view of a portion of the clip delivery memberillustrated in FIG. 23.

FIG. 25 is an isometric view of a portion of the clip delivery memberillustrated in FIGS. 23 and 24 showing a clip positioning loop extendingfrom the exterior of the clip delivery member.

FIG. 26 is an isometric view of a portion of a clip delivery member ofthe type generally illustrated in FIGS. 23 through 25 showing a clipdelivery positioning loop extending from the exterior of the clipdelivery member.

FIG. 27 is a broken, partially sectioned side view of the clip deliverymember illustrated in FIG. 26 in place within tissue ready to eject aclip into place to close an aperture.

FIG. 28 is a front view of a fourth embodiment of a clip in accordancewith the invention where the clip illustrated in FIG. 28 is similar tothe embodiment illustrated in FIGS. 1 through 6, 13 and 14, thedifference being that the embodiment of the clip illustrated in FIG. 28has a planar upper portion.

FIG. 29 is a top view of the embodiment of the clip illustrated in FIG.21 fabricated without loading loop 210 illustrated in FIG. 21.

FIG. 30 is a sectional view of the clip illustrated in FIG. 29 taken atlines and arrows 30-30 in FIG. 29.

FIG. 31 is a front view of the clip illustrated in FIG. 29.

FIG. 32 is a broken sectional view of the clip illustrated in FIGS. 29through 31 taken at lines and arrows 32-32 in FIG. 31.

FIG. 33 is a broken vertical section illustrating deployment of a clipin accordance with the third embodiment of the invention to close anaperture and a vessel wall with the clip undeployed and fully within theclip delivery apparatus.

FIG. 34 is a broken vertical section similar to FIG. 33 but with theclip 10-4 partially ejected from the delivery apparatus and in the firststage of deployment.

FIG. 35 is a partially broken vertical section similar to FIGS. 33 and34 depicting clip 10-3 fully deployed in a vessel of interest, closingan aperture within the vessel by action of extremity portions 12-3penetrating the vessel wall on both the inside and the outside of thevessel and drawing the vessel wall radially and leaving thereby to closethe aperture of interest.

DETAILED DESCRIPTION OF THE INVENTION

This invention provides apparatus and methods for closing a tissueaperture, particularly a vascular or vessel (the two terms being usedinterchangeably herein) aperture, resulting from insertion of a surgicalimplement or from accidental trauma or from disease. The inventionembraces both apparatus and method aspects of devices for closing avascular aperture and apparatus and method aspects of second devices fordelivering the closure apparatus into the aperture being closed. Theclosure apparatus preferably has at least a portion formed of a memorymaterial, preferably metal, which, when deformed from its stress-freestate, seeks to return to the stress-free state. The stress-free statecorresponds to the state at which the apparatus has closed an aperturein a vessel. In conjunction with the delivery apparatus of theinvention, the closure apparatus provides a two-step, ratchet-likeaction closing the aperture of interest while acting to draw asubcutaneous tissue exterior to the vessel towards the aperturesimulating manual compression.

In the drawings tissue closure clips in accordance with the inventionare designated generally 10. Four different embodiments of the inventionare respectively identified 10-1, 10-2, 10-3 and 10-4 in the drawings.The embodiment of the tissue closure clip identified as 10-1 in FIGS. 1through 10, 13 and 14 is the preferred embodiment of tissue closure clipapparatus in accordance with the invention.

In the first embodiment in which the clip is designated generally 10-1 acentral portion 14 leads into a pair of upper horizontally extendingside arms 30 and into two lower elongated strand portions 12 thatfunction to at least contact and preferably pierce the vessel wall andclose the aperture.

Referring to FIGS. 1 through 5, 13 and 14, clip 10-1 for closing anaperture in a vessel includes a first portion 200 forming an arc. Asecond portion 202 extends transversely from first portion 200 relativeto the arc where the arc is designated generally 204 in the drawings. Athird portion 206 extends from second portion 202 remotely from firstportion 200 and curves progressively, relative to second portion 202,initially towards first portion 200 and then towards second portion 202.A tip 18 of third portion 206 is adapted for piercing and retainingtissue encountered thereby.

In the drawings and particularly in FIG. 13 it is seen that secondportion 202 embraces central portion 14. Third portion 206 embraces apair of transition portions 24 which are located between central portion14 and a central segment 26 of third portion 206. Still referring toFIG. 13, third portion 206 further includes a curved transition portion28 extending between third portion central segment 26 and a tip 18.

Clip 10-1 is preferably formed from a single strand of material andhence includes two third portions 206 formed at respective ends of thestrand. Each third portion 206 includes a transition portion 24, acentral segment 26, a transition portion 28 and a tip 18, all asillustrated in FIG. 13.

Still referring to the same drawing figures and particularly to FIG. 13,first portion 200 includes a pair of curved transition junctures 22connecting first portion 200 with second portion 202, namely withcentral portion 14. Each transition juncture 22 leads in turn to apreferably straight segment 23.

Referring to FIGS. 15 through 19 illustrating the embodiment of the clipdesignated generally 10-2, a central stem 76 extends from an uppersaddle configuration and supports four elongated extending portions 89that function to pierce the vessel wall and close the aperture.

Referring to FIGS. 20 through 22 in which the clip is designatedgenerally 10-3, a central region 19 supports a plurality of upper andlower elongated strands 12-3 functioning to pierce the vessel wall fromabove and below to close the aperture.

Clip 10-1 is preferably memory metal and has an unstrained conformationillustrated in FIG. 1. Referring to FIG. 2, clip 10-1 may be beconsidered to have upper and lower halves designated 64 and 66respectively.

Central portion 14 is coincident with a central vertical axis designatedA and drawn in FIG. 2 for reference purposes. Central portion 14 extendsinto both upper half 64, wherein extending side arms 30 extendhorizontally and upwardly from central portion 14, and into lower half66 wherein third portions 206 extend downwardly and outwardly fromcentral portion 14. Central portion 14 includes two preferablytangentially contracting segments, where the position of tangency isdesignated 15.

Referring to FIGS. 4 and 5, upper half 64 comprises a FIG. 8configuration forming a central crossover juncture 36 which definescommencement of horizontally extending side arms 30 denoted by thebrackets in FIG. 4.

Preferably, angular expansion of horizontally extending side arms 30from the central midpoint within the FIG. 8 configuration is, asindicated by angle X in FIG. 5, approximately 62.7°. In the preferredembodiment clip 10-1 preferably has a loop diameter of about 0.15 inchesdenoted by dimensional indicator C in FIG. 5 and a horizontal crosswidthof about 0.441 inches, denoted by dimensional indicator D in FIG. 5.

As is apparent from FIG. 9, when clip 10-1 has deployed and closed anaperture in a vessel 11, upper half 64 preferably extends externally tonow closed vessel 11, horizontally extending side arms 30 resideproximate to and preferably contact exterior surface 13 of vessel 11 andundersides 31 of horizontally extending side arms 30 preferably contactexterior surface 13.

Lateral extremities of upper half 64 preferably are about 0.037 inchesbelow the center of upper half 64, namely crossover junctures 36, asindicated by dimensional indicator E in FIG. 2.

Lower half 66 includes a part of central portions 14-1 extending leadinginto elongated portions of strand 12-1 which define third portion 26-1and function to pierce the tissue of vessel 11, closing the aperture.Referring to FIG. 9A the parts of deployed elongated strand 12 definingthird portion 206 preferably extend within the tissue surrounding theaperture closed in vessel 11.

Referring to FIG. 13, clip 10-1 comprises several transition portions.Coincident with central vertical axis A is central portion 14, whichpreferably includes two vertical segments which lead to third portion 26defined in part by two curved transition portions 24. Central portion 14also leads to first portion 29 which is defined in part by upwardlycurved transition portions 22 leading to horizontally extending sidearms 30.

Referring to FIG. 3, central portion 14 comprises two vertical segments;a point of tangency 15 between those segments is coincident withvertical axis A. FIG. 3 illustrates that the two vertical segmentscomprising central portion 14 preferably are mutually offsetequidistantly from vertical axis A; these portions of elongated strand12 are preferably separated by one hundred eighty degrees (180°).

Referring to FIGS. 4 and 5, third portions 206 of elongated strand 12preferably are mutually offset and preferably equidistant from oneanother on opposite sides of vertical axis A which is not shown in FIGS.4 and 5.

Referring to FIG. 13, transition portion 24 defines the beginning of thethird portions 206 of elongated strand 12, which initially extenddownwardly and then curve upwardly leading into upwardly extendingcentral segment 26 of third portion 206. Upwardly extending centralsegment 26 defines transition from curved portion 24 to the curvedtransition portion 28 of third portion 206. Curved loop transitionportion 28 leads to the ends, namely the tip or terminus end portions18, of elongated strand 12. Tips 18 preferably are tapered to a sharppoint functioning to easily penetrate tissue.

Transition junctures 22 lead to straight segments 23 which in turn leadto the beginning of outwardly curved portions 32 of horizontallyextending side arms 30, all being a part of first portion 200. Twooutwardly curved portions 32 preferably extend horizontally and hencetransversely with respect to preferably vertical central portion 14 todefine horizontally extending side arms 30 wherein transition portions34 define the radial outward extremities of curved portions 32.

FIG. 2 illustrates the preferably slight downward curvature ofpreferably substantially horizontally extending side arms 30. Coincidentwith vertical axis A is an upwardly curved crossover juncture 36creating a catch 37 for insertion of a guide wire 54 therethrough fordrawing clip 10-1 into an ejection chamber 56 such as shown in FIG. 11.

As illustrated in FIG. 13 transition between preferably substantiallyhorizontally extending side arms 30 and crossover juncture 36 is definedby an upwardly curved portion 35 defining catch 37.

Referring to FIG. 6 when clip 10-1 is loaded into a device fordeployment of clip 10-1 to close a vessel aperture, clip 10-1 is in astrained extended configuration, as illustrated.

A front end 52 of a suitable clip delivery member 20 is depicted in FIG.6. Clip 10 is shown within ejection chamber 56 which accommodates clip10-1 in a constrained, narrow, extended configuration. Front end 52 isdefined by a hollow tubular opening 53 of clip delivery member 20wherein hollow tubular opening 53 facilitates ejection of medical clip10-1.

FIG. 7 shows insertion of front end 52 of clip delivery member 20 withclip 10-1 therein into an aperture within a vessel 11. As illustrated inFIG. 7, commencement of ejection to deploy clip 10-1 moves clip 10-1towards front end 52 of ejection chamber 56.

In FIG. 7 clip 10-1 is depicted in the process of being deployed at theintermediate position. FIG. 6 illustrates clip 10-1 in the initialposition. Clip 10-1 is pushed by push rod 44 acting in response to thumbpressure applied to firing button 48 and moves from the positionillustrated in FIG. 6 to a position at which third portion 206 of clip10-1 extends outwardly from ejection chamber 56 while first portion 200of clip 10-1 remains within ejection chamber 56. The intermediateposition of clip 10-1 defining the first of the two ratchet-like stagesof clip deployment is illustrated in FIG. 7 with clip 10-1 at positionto initiate the second stage of deployment with third portion 206 ofclip 10-1 extending radially outwardly as clip 10-1 endeavors to relieveitself of internal stresses. As a result tips 18 have encountered asurface portion of vessel 11 at the position illustrated in FIG. 7. Asclip 10-1 is further ejected from ejection chamber 56 in the directionindicated by arrow A in FIG. 7 third portions 206 continue to curve,seeking to reach the position illustrated substantially in FIG. 8. Asthird portions 206 continue to curve, tips 18 penetrate wall 15 ofvessel 11 and urge the respective penetrated portions of wall 15 andvessel 11 towards one another, radially inwardly with respect to axis Ain FIG. 1. Continued curvature of third portions 206 as tube 55 isremoved from vessel 11 permits third portions 206 to reach theirconfiguration whereby they are at least substantially free of internalstresses, as shown generally in FIG. 9A thereby closing the aperture ofinterest in vessel 11 as illustrated in FIGS. 9 and 9A.

In the event the physician or other attending health professional wishesto reposition clip 10-1 in the midst of the procedure, the physician orother attending health professional may draw clip 10-1 back into tube 55in the direction indicated by arrow B in FIG. 7 by pulling on pull ring46 having wire 54 connected thereto, neither of which are illustrated inFIGS. 6 through 9A but which preferably runs through tube 55 to ring 46in FIG. 11. Of course, in the event the physician or other healthprofessional has disconnected wire 54 from pull ring 46 the only courseof action remaining for the physician or other attending healthprofessional is to advance push rod 44 thereby fully deploying clip 10-1in the position to close the aperture as illustrated in FIGS. 9 and 9A.

Grooves 58 in front end 52 of clip delivery member 20 guide thirdportions 206, which normally extend horizontally when clip 10-1 isdeployed and has relieved itself of internal stresses, when the clip isloaded into delivery member 20. Movement of clip 10-1 is depicted by anarrow within ejection chamber 56 denoting the downward direction ofejection of clip 10-1 from ejection chamber 56.

An enlarged view of front end 52 of clip delivery member 20 shown inFIG. 10 illustrates grooves 58.

Deployment of clip 10-1 from within ejection chamber 56 into a vessel isdepicted in FIG. 8 wherein tips 18 of elongated strand 12 are shownadvancing upwardly and laterally thereby piercing peripheral tissue.Preferably, tips 18 taper to a sharp point, to easily penetratesurrounding tissue.

As apparent from FIGS. 9 and 9A upward and lateral motion of tips 18 ofelongated strand 12 is complete once tips 18 are proximate with centralportion 14.

Tips 18 may penetrate exterior surface tissue 13 of a vessel 11 withoutpassing entirely through the tissue of vessel 11. Alternatively, tips 18may penetrate entirely through vessel 11 or other tissue in which anaperture is to be closed with the tips extending out of the exterior ofthe vessel or other tissue in which an aperture is to be closed. As yetanother alternative, tips 18 may be dull and serve only to press againstthe surface of tissue surrounding an aperture to be closed, with 18 tipsserving to draw the tissue together without penetration of the tissue bytips 18. The clip may be provided with tips 18 sharpened or dulldepending upon the clinical used for the particular clip of interest.

Referring again to FIGS. 9 and 9A, when clip 10-1 is fully deployed,upper horizontally extending side arms 30 preferably remainsubstantially outboard of the aperture of the vessel, the undersides 31of horizontally extending side arms 30 preferably are in contact withthe vessel tissue.

Referring to FIGS. 15 through 20 in another aspect of the invention aclosure clip has a saddle configuration wherein elongated strandportions 89 extend from a stem 76 supported by a saddle shaped bottompiece 108. Considering for purposes of reference a three dimensionalcoordinate system having axes X, Y and Z as illustrated in FIG. 15, amidpoint of stem 76 defines the origin of the X, Y, Z coordinate system.Coincident with the Y axis is a position from which four curvingextremity portions 89 extend first in a generally upwardly directionalong the Y axis and transition to gradually curving in an outwardlydirection. Saddle portion 75 extends three dimensionally in the X-Zplane and curves downwardly in the Y-Z and X-Y planes.

Still referring to FIGS. 15 through 20, stem 76 includes sections 78, 82and 86. Base portion 78 transitions to an exterior upper surface 120 ofdownwardly curved saddle portion 75 providing juncture between saddle 75and stem 76. Surface 77 of base portion 78 curves outwardly totangentially join exterior surface 120 of downwardly curved saddleportion 75.

An upper end of base portion 78 transitions to mid-stem support piece 82through juncture 80. Mid-stem support piece 82 transitions to top stemclosure piece 86 through juncture 84. Stem 76 is the anchor forextending portions 89. Generally, each of four curved extending portions89 extend in a linear upwardly direction out of piece 90 and arecoincident with each other at a position of tangency 91.

Areas of transition 94 define transition from upwardly and outwardlycurved portions 92 to peak central portions 96 wherein peak centralportions 96 define the parts of curved extending portions farthest fromexterior surface of curved saddle portion 75. Peak central portions 96transition into outwardly and downwardly curved portions 98 which inturn transition to outwardly curved portions 100 defining the portionfarthest from piece 90. Outwardly curved portions 100 transition intoinwardly curved portions 102 thereby transitioning to front end portions104 terminating in tips 106. Preferably tips 106 comprise a sharp pointto pierce tissue surrounding the aperture to be closed. Exterior surface120 of saddle 75 meets juncture segment 74 defining commencement of stem76.

Saddle portion 75 has a circular periphery and a configuration in whichtwo opposing sides curve downwardly with transition portions 116 beinglower than transition portions 118.

Preferably, to form the saddle configuration the sides of saddle portion75 curve downwardly to transition portions 116, continue therethrough toupwardly curved portions 115 and then to transition portions 118.

Referring to FIG. 16, curved extending portions 89 when relaxed extendoutwardly towards the four transition portions 116, 118, 116 and 118respectively.

In FIG. 16 the downward curvature of saddle 75 is depicted. Tips 106 ofportions 89 are proximate with but separated from transition portions116 and 118.

Referring to FIGS. 15 through 20, sides 124 of saddle configurationbottom piece are preferably curved. Curvature of sides 124 preventsabrasion within the vessel and midlines discomfort to the patient.

FIGS. 18 and 19 illustrate that bottom surface 122 transitions to curvededges 124. Rotation of saddle configured bottom piece 108 about the Xaxis by 180° is depicted in FIG. 19 wherein portions 89 extend beyondcircumferential curved edge 124 of saddle 75.

Referring to FIGS. 20 and 21, a third embodiment of a tissue closureclip manifesting aspects of the invention is designated generally 10-3and preferably includes a plurality of elongated strands, where theindividual strands are designated generally 12-3 in FIGS. 20 and 21.Strands 12-3 may be single filaments or may be woven or braided or otherarrangements of multiple sinuous members. Each elongated strand 12-3preferably has a central portion and two (2) extremity portionsextending in either direction from the central portion. Individualcentral portions of the elongated strands 12-3 are designated 14-3 whileextremity portions of each elongated strand 12-3 are designated 16-3.Each extremity portion 16-3 terminates in a tip, where the tips ofindividual extremity portions are individually designated 18-3. Each tip18-3 of an extremity portion 16-3 is shaped to retain tissue about theperiphery of an aperture, which tissue is encountered by a tip 18-3 oftissue closure clip 10-3 as clip 10-3 deploys upon release from or by adelivery member. A portion of one suitable delivery member isillustrated in FIG. 22; the illustrated portion is designated generally20 therein.

As apparent from FIG. 21 a plurality of elongated strands 12-3,preferably comprised of memory metal, originate from a central region19-3 wherein elongated strands 12-3 and a longitudinally extendingloading wire 210 are retained within a central band 21-3.

Elongated strands 12-3 preferably extend upwardly and downwardly fromcentral region 19-3; band 21-3 retains central portion 14-3 of elongatedstrands 12-3. Elongated strands 12-3 curve outwardly from centralportion 14-3.

A longitudinally extending load wire loop 210 preferably extends fromwithin central region 19-3 and is constrained by band 21-3. Loading wire54 loops through loop 210 to draw medical clip 10-3 into ejectionchamber 56-3.

Referring to FIG. 22, front end 52-3 of clip delivery member 20-3 isdepicted in the course of ejecting clip 10-3 from ejection chamber 56wherein elongated strands 12-3 are in a linear, constrainedconfiguration. Upon ejection, elongated strands 12-3 curve outwardlyfrom central region 19-3, contacting and preferably piercing tissueabove and below the center of the clip. Clip 10-3 differs from clips10-2 and 10-1 in providing bilateral aperture closure, above and belowthe clip center, inside and outside of the vessel of interest.

Referring now to FIG. 11, a preferred embodiment of a clip deliverymember according to one aspect of the invention is designated generally20 and functions to eject a clip 10, preferably the preferred embodimentof clip 10-1, to close a vessel aperture. In one embodiment clipdelivery member 20 comprises a longitudinally extending housing 40receivably housing a push rod 44 which is manually activated by pushinga “firing” button 48 wherein firing button 48 is separable from anassociated pull ring 46. Push rod 44 is basically contacted by firingbutton 48 with the end of push rod 44 opposite from that contacted byfiring button 48 contacting an upper end of a clip 10 to force the clipout of tube 55 in a two stage ratchet-like action as described above.

Preferably, side arms 50 extend outwardly, perpendicular tolongitudinally extending chamber 38, facilitating manual “firing” ofclip 10 and manual aim of clip delivery member 20. Side arms 50 may begrasped by an operator, using the fingers while the thumb may be used to“fire” push rod 44 with firing button 48.

Referring to FIG. 11, within front end 52 is a hollow chamber 56 ofadequate sizes to receive clip 10-1. Top portion of clip 10-1 contactsdistal end 69 of push rod 44 where push rod 44 linearly extends withinlongitudinally extending chamber 56. A proximal end 68 of push rod 44facingly contacts cylindrical firing button 48 which in turn isconnected to, yet detachable from, a pull ring 46.

An expanded view of an optionally configured front end 52 of clipdelivery member 20 illustrated in FIG. 10 shows front end 52 having ahollow tubular opening 53 with two grooves 58 are angularly positioned180° apart. As wire 54 connected to ring 46 in FIG. 11 is drawn bypulling ring 46, clip 10-1 is drawn into front end 52 by having firstportion 200 distend upwardly in the direction of vertical axis Aillustrated in FIGS. 1 and 2 so that third portions 206 extend thefarthest radially outwardly of any portion of clip 10-1. Referring toFIG. 11, clip 10-1 is drawn into front end 52 by loading wire 54 whereinloading wire 54 loops through crossover juncture 36 of closure clip 10-1and attaches to pull ring 46.

Push rod 44 ejects clip 10-1 by urging the upper portion 64 of clip 10-1downwardly out of ejection chamber 56.

Clip 10-1 facilitates rapid closure of a tissue aperture. Preferably,clip 10-1 is constructed of memory metal and when unconstrained assumesthe configuration illustrated in FIGS. 1 through 6. The memory metalconstruction of clip 10-1 allows clip 10-1 to be constrained in anelongated conformation, for example when within ejection apparatus 20depicted in FIG. 6. Upon ejection, clip 10-1 preferably piercesproximate tissue and pulls the tissue together when clip 10-1 coils toits unconstrained configuration.

In another aspect of the invention an optional front end 52 of apreferred embodiment of clip delivery member 12 is depicted in FIGS. 23through 27. In this aspect of the invention tube 55 contains twolongitudinally extending side chambers 128 angularly positionedequidistant from each other.

Side chambers 128 contain strips 130 of memory metal that may extendthrough apertures 126 located on opposite sides of tube 55 equidistantfrom each other within front end 52 of clip delivery member 12.

Referring to FIGS. 23 through 25, extension of memory metal strip 130through aperture 126 results in formation of a loop 140 proximate thefront end 52 of clip delivery member 12.

Referring to FIGS. 26 and 27 dual side loops 140 act to position clip 10properly within a vessel. FIG. 27 illustrates positioning of clipdelivery member 12 within a vessel.

In FIGS. 24 and 25 only one longitudinally extending side chamber 128 iscontained within tube 55 wherein loop 140 is formed through one aperture126. Referring to FIG. 23, positioning within the vessel is accomplishedby one loop 140 rather than two.

Ejection of clip 10 may be accomplished with or without loops 140.

In operation, medical clip 10 returns to the unconstrained configurationrapidly to seal the aperture with minimal discomfort to the patient.

Referring to FIG. 28 illustrating a fourth embodiment of a clipmanifesting the invention where the clip is designated generally 10-4,clip 10-4 is preferably fabricated with an angle between vertical axis Aand a line parallel with upwardly extending central segment 26-4 ofthird portion 204 equal to about thirty degrees (30°) where this angleis indicated by indicator AA in FIG. 28. Clip 10-4 is fabricatedpreferably with space between first portion 200-4 and the verticallyupper extremity of third portion 206-4, designated by dimensionalindicator BB in FIG. 28, being about 0.037 inches.

Clip 10-4 is further preferably fabricated with the radii of the arcsdefining transition portion 24-4 between second portion 202-4 andforming the transition thereof into third portion 206-4 is formedpreferably having a radius of about 0.048 inches as indicated by arrowCC in FIG. 28 and with transition 28-4 between the central part of thirdportion 206 and tip 18-4 being formed on a radius of about 0.063 inchesas indicated by DD in FIG. 28.

Clip 104 illustrated in FIG. 28 is further preferably fabricated havinga distance of about 0.119 inches between vertical axis A and the redialouter extremity of third portion 206 as indicated by dimensionalindicator EE in FIG. 28.

Clip 104 is further preferably fabricated such that clip 10-4 has anoverall height of about 0.206 inches as indicated by dimensionalindicator FF in FIG. 28. Clip 10-4 is further preferably fabricatedhaving a distance from the underlying surface of first portion 200 to alocale of transition between central portion 14 and third portion 206 asindicated by dimensional indicator GG in FIG. 28 of about 0.150 inches.

While the invention has been described with respect to closing aperturesand vessels, the invention is not limited to this. Specifically, theinvention has applicability to closing laparoscopic portals, to pistulawhich are leaks in the bowel to closing holes in the heart to dealingwith froamen ovals, congenital holes, ventricular central defects,arterial central defects and other apertures in the aorta and associatedpulmonary arteries and veins.

1. A surgical apparatus for closing a vessel aperture extending througha vessel wall of a patient comprising: a. a horizontally extendingmember having first and second end portions and an intermediate portion,the horizontally extending member adapted to be positioned on a firstside of the vessel aperture internal of the patient; b. elongated strandportions having extremity portions curving inwardly adapted to bepositioned on a second side of the vessel aperture internal of thepatient, the extremity portions having shape memory characteristicsseeking to cause said extremity portions to curl to retain tissueengaged thereby when delivered from a delivery member and in anunconstrained position, the extremity portions extend in a directiontoward the horizontally extending member, each of the strand portionsforming a loop; and c. a central portion having an outer surface andadapted to extend through the vessel wall between the intermediateportion of the horizontally extending member and the elongated strandportions wherein the horizontally extending member extends a furtherlateral distance from a longitudinal axis of the central portion than alateral distance the elongated strand portions extend from thelongitudinal axis when delivered from the delivery member, thehorizontally extending member configured to remain spaced from thestrand portions on the first side of the aperture and extending along anaxis transverse to the longitudinal axis of the central portion, thestrand portions extending from the central portion and curling radiallyoutwardly away from the outer surface of the central portion and curlingback toward the outer surface of the central portion forming first andsecond loops alongside the central portion.
 2. The apparatus of claim 1,wherein the elongated strand and central portions are formed from asingle strand of material.
 3. Apparatus of claim 1, wherein saidhorizontally extending member is configured to contact an exteriorsurface of a vessel.
 4. Apparatus of claim 3, wherein said horizontallyextending member is configured as a figure eight.
 5. Apparatus of claim3, wherein the horizontally extending member includes a loop. 6.Apparatus of claim 1, wherein said horizontally extending member isconfigured as a figure eight.
 7. Apparatus of claim 1, wherein theextremity portions have tips configured to pierce the tissue. 8.Apparatus of claim 1, wherein, the apparatus has an extendedconfiguration for delivery through the vessel wall.
 9. Apparatus ofclaim 1, wherein each of the elongated strand portions has an arcseparated by a straight segment.
 10. Apparatus of claim 1, wherein thehorizontally extending member forms an arc.
 11. Apparatus of claim 10,wherein the central portion extends transversely relative to the arc.12. Apparatus of claim 1, wherein the extremity portions curve initiallytoward the horizontally extending member and then toward the centralportion.
 13. Apparatus of claim 1, wherein the elongated strand portionsform a lower half and the horizontally extending member forms an upperhalf with the central member extending to both halves.
 14. Apparatus ofclaim 1, wherein the horizontally extending member is configured tocontact the vessel.
 15. Apparatus of claim 14, wherein the horizontallyextending member includes two outwardly curved portions.